DOXPUB 15-0009-SOP

Summary:

Describes a method for determining the content of colony forming units-megakaryocyte (CFU-MK) by plating a known number of hematopoietic cells in a dish and enumerating the number of colonies generated after 14 days. Applies to the set-up and enumeration of CFU-MK. Applies to assays performed by R&D personnel. Includes instructions for reagent preparation, plate setup, fixing, immunocytochemistry staining, and CFU-MK enumeration.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

CFU-Mk Reagent Preparation Worksheet, CFU-Mk Preparation Worksheet, CFU-Mk Staining Worksheet

About This Document:

This is not a generic template, it's a 10-page procedure that was actually created and used in the Laboratory R&D operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

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